K-number	K192691
Device name	PatCom Single-Use Introducer
Applicant	H&A Mui Enterprises, Inc.
Product code	FED
Device class	Class II
Decision date	Feb 21, 2020
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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PatCom Single-Use Introducer

Everything you need for a 510(k) submission. Nothing you don't.